210. switching to Biosimilars: An Early Clinical Review

Rabbitts, Roberta; Jewell, Teresa; Marrow, Kui-leng; Herbison, Clare; Laversuch, Catherine

doi:10.1093/rheumatology/kex062.211

Cited by 4 publications

(1 citation statement)

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“…Treatment discontinuations among patients who undergo nonmedical switch from an originator TNF inhibitor to its biosimilar and subsequent failure to maintain treatment response or experience an adverse event could be explained by the nocebo effect in many instances. This has been reported particularly following a mandated nonmedical switch in stable patients who had been doing well with their previous therapy [11,[36][37][38][39]. However, the current evidence regarding this is limited, as it is difficult to identify or quantify, especially retrospectively.…”

Section: Nocebo Effectmentioning

confidence: 99%

Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Fleischmann

Jairath

Mysler³

et al. 2020

Rheumatol Ther

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The act of nonmedical switching, defined as switching stable patients who are generally doing well with their current therapy from an originator biologic to its biosimilar, has been endorsed as a reasonable treatment strategy. The safety and efficacy of nonmedical switching have been evaluated in randomized controlled and real-world evidence studies, which have demonstrated that although many patients maintain treatment response after the switch, some patients experience therapy failure, resulting in therapy discontinuation. It has been postulated that the vast majority, if not all, of these treatment failures result from a ''nocebo effect'', defined as patients' negative expectations toward the therapy change. Reports suggest that the risk of a nocebo effect is higher following a mandated nonmedical switch. Although the nocebo effect is a well-recognized phenomenon in pain studies, evidence is limited in immune-mediated diseases primarily because it is difficult to quantify, especially retrospectively. In spite of this, numerous biosimilar studies in patients with immunemediated diseases have concluded that nonmedical switching failures are due to a nocebo effect. The objective of this narrative review was to explore the reasons for nonmedical switch failure or discontinuation and the role of the nocebo effect among patients with inflammatory rheumatic and gastrointestinal diseases who switched from an originator biologic to its biosimilar.

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Section: Nocebo Effectmentioning

confidence: 99%

Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Fleischmann

Jairath

Mysler³

et al. 2020

Rheumatol Ther

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Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to Their Biosimilars: Systematic Review of Randomized Controlled Trials and Real-World Studies

Numan

Faccin

2018

Adv Ther

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Tumor necrosis factor (TNF) inhibitors are widely used biologics for the treatment of several chronic inflammatory diseases. The launch of anti-TNF biosimilars has introduced the possibility of non-medical switching between originator biologics and their biosimilars. However, the potential clinical and patient-reported consequences of non-medical switching remain largely unknown, as much of the evidence comes from poorly or uncontrolled real-world evidence (RWE) studies that often have an element of bias and nonstandardized outcome measures. To appropriately evaluate the safety, efficacy, and immunogenicity of non-medical switching from an originator to its biosimilar, we propose that seven key study design elements should be considered when assessing the existing evidence: studies should be (1) randomized and double-blind, (2) adequately controlled, and (3) adequately powered; include (4) multiple switching, (5) an assessment of immunogenicity, and (6) adequate follow-up duration; and (7) report individual patient-level outcomes. This systematic review assessed the robustness and consistency of the current non-medical switching evidence, with a focus on TNF inhibitors. A comprehensive literature search (January 2012–February 2018) identified 98 publications corresponding to 91 studies (17 randomized controlled trials and 74 RWE studies) describing non-medical switching from a TNF inhibitor originator to its biosimilar. When assessing the totality of this evidence, none of the non-medical switching studies conducted to date were found to use all seven of the key design elements, and the absence of these elements dilutes the robustness of the data. Furthermore, discontinuation rates varied widely among studies (0–87%), suggesting heterogeneity and inconclusiveness of the current efficacy, safety, and immunogenicity evidence, particularly at an individual patient level. Therefore, patients should not be indiscriminately switched from an originator TNF inhibitor to its biosimilar for non-medical reasons. Switching decisions should remain between the treating physicians and their patients and be made on a case-by-case basis, relying upon robust scientific evidence.Funding: AbbVie.Plain Language Summary: Plain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s12325-018-0742-9) contains supplementary material, which is available to authorized users.

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SB4 (Benepali®; an etanercept biosimilar): a profile of its use

Lyseng‐Williamson

McKeage

2017

Drugs Ther Perspect

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210. switching to Biosimilars: An Early Clinical Review

Cited by 4 publications

References 0 publications

Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Nonmedical Switching From Originators to Biosimilars: Does the Nocebo Effect Explain Treatment Failures and Adverse Events in Rheumatology and Gastroenterology?

Non-medical Switching from Originator Tumor Necrosis Factor Inhibitors to Their Biosimilars: Systematic Review of Randomized Controlled Trials and Real-World Studies

SB4 (Benepali®; an etanercept biosimilar): a profile of its use

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